FDA Approves New Multiple Sclerosis Drug

FDA Approves New Multiple Sclerosis Drug

Good news for the two and a half million Americans who suffer from multiple sclerosis (MS). The Food and Drug Administration has approved a new, once-a-day tablet for the treatment of adults with relapsing forms of the disease.

The drug teriflunomide, which is marketed under the brand name Aubagio by the French drug maker Sanofi (NYSE: SNY), is expected to be available for prescription by October. It could give relief to up to 40 percent of MS sufferers who take no medication due to the side effects associated with other forms of treatment.

Currently, the only other oral medication for MS is fingolimod, which is sold by Novartis (NYSE: NVS) under the brand name Gilenya. The drug is known to slow the heart rate, especially in the first 30 days of its use.

Most first-line medications used to treat MS are injected, and that makes the convenience of a once-daily pill attractive to patients. Sanofi estimates a year’s worth of treatment with Aubagio will cost about $45,000, which is cheaper than other MS drugs. Worldwide sales of MS drugs are worth about $12 billion annually and are dominated by injectables.

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

Multiple sclerosis involves immune system attacks on the brain and spinal cord that disrupt communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men.

Aubagio inhibits the function of immune cells that have been implicated in MS and is related to leflunomide, a drug used to treat arthritis. In a recent study, the drug was shown to reduce the risk of MS relapses by about 30 percent.

For most people with MS, relapses are initially followed by recovery periods or remissions. Over time, recovery periods may be incomplete, leading to progressive decline. There is no cure for the disease.

Though clinical trials have shown Aubagio to be safe and well tolerated, it does have side effects. The most common include diarrhea, abnormal liver tests, nausea, flu, and hair thinning.

The FDA recommends that physicians should do blood tests to check liver function before a patient starts taking Aubagio, and periodically during treatment. Patients should also have their blood pressure checked and have a screening test for tuberculosis. Because Aubagio may cause hard to a fetus, the drug is also labeled by the FDA as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.

Authored by: Richard Lenti